India

DCGI grants emergency use nod to Corbevax jab for 12-18 age group

The Drugs Controller General of India (DCGI) on Monday gave the emergency use nod to Biological E’s Covid-19 vaccine Corbevax for the 12-18 age group.
Currently, India only adminers Bharat Biotech’s Covaxin to those in the 15-18 age group. The government’s expert panel on vaccine adminration is expected to meet soon to decide on expanding the Covid-19 vaccination coverage to 12-year-olds.

Corbevax is India’s first indigenously developed Receptor Binding Domain (RBD) Protein sub-unit vaccine against Covid-19. The vaccine received emergency use authorisation for the adult population in December last year. However, it is yet to be used in the Covid-19 immunisation drive.
Corbevax is built on the traditional subunit vaccine platform. Instead of using the whole virus, the platform triggers an immune response using its fragments, like the spike protein. The sub-unit vaccine contains harmless S-protein. Once the human immune system recognises the S protein, it produces antibodies as white blood cells that fight the infection.
“We are pleased with this significant development, which helps extend the reach of our vaccine to the age group of 12 to 18 years in our country. We truly believe that with this approval, we are even more closer to finishing our global fight against the Covid-19 pandemic. Once fully vaccinated, children can resume their activities and educational pursuits in schools & colleges without any apprehension,” Mahima Datla, Managing Director, Biological E. Limited, said.
Last September, Biological E received approval to conduct a Phase II/III clinical trial of Corbevax among those aged 5 to 18 years. Based on the no-objection certificate, the company initiated the clinical study in October 2021 and evaluated the available safety and immunogenicity results of the ongoing phase II/III study. The company said that these late-stage clinical trials have indicated that the vaccine is safe and immunogenic.

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